September 26, 2007 Update from the FDA website According to the FDA website, pain drug Fentora (fentanyl buccal tablet) has been linked to serious and fatal side effects in cancer patients who were not appropriately screened for the receiving the drug. The manufacturer of the drug, Cephalon, issued letters to physicians and healthcare professionals on the proper use of the drug in the right patient type. Here is part of the letter relating to Key safety information for Fentora:
- Do not use Fentora in opioid non-tolerant patients
- Use Fentora only for labeled indications
- Do not prescribe Fentora for patients with acute pain, postoperative pain, headache/migraine, or sports injuries
- Fentora is not a generic version of Actiq. Therefore, do not substitute Fentora for Actiq or other fentanyl-containing products
- Follow dosing instructions carefully:
- For unrelieved breakthrough pain (BTP), patients should not take mor than 2 Fentora tablets per BTP episode
- Patients must wait at least 4 hours before treating another BTP episode with Fentora